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Senior Process Development Engineer

2 months ago


Painesville, Ohio, United States Olon Ricerca Bioscience LLC Full time
Job Summary

We are seeking a highly skilled Senior Process Development Engineer to join our team at Olon Ricerca Bioscience LLC. As a key member of our process development team, you will be responsible for the scale-up and preparation of pharmaceutical and specialty chemicals.

Key Responsibilities
  • Process Development and Scale-Up: Collaborate with chemists to develop new chemical processes, translate these processes into executable instructions, and guide operators through production.
  • Process Optimization: Provide guidance in scaling up production processes from the lab to the pilot plant, and develop flexible solutions when processes do not scale as expected.
  • Documentation and Compliance: Create and maintain supporting documentation (batch records, specifications, hazard sheets, safety review packages, air emissions, processing reports) necessary to support processing in the plant.
  • Team Collaboration: Interact closely with our chemistry and quality departments throughout the production process, and participate in safety meetings and reviews.
  • External Interactions: Meet with clients, vendors, and contractors to discuss process development and scale-up requirements.
  • Engineering Support: Provide engineering support for pilot plant infrastructure and equipment commissioning/qualification.
Requirements
  • Education: B.S. or M.S. in Chemical Engineering or Chemistry.
  • Experience: 10 or more years of experience in scale-up/preparation of pharmaceutical and specialty chemicals.
  • Skills: Strong problem-solving capabilities, experience in first-time scale-up and preparation, demonstrated success in prior positions, and knowledge of process/cleaning validation and equipment commissioning/qualification.